PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR
FDA 510(k) clearance K122805 · decided 2013-02-05
Clearance details
- K-number
- K122805
- Device name
- PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR
- Applicant
- Parcus Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2012-09-13
- Decision date
- 2013-02-05
- Days to decision
- 145 days
- Clearance type
- Traditional
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Sturgeon Bay, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.